Process Development Engineer (cGMP – Pharmaceutical – Gene Therapy)

Full-time

Downstream Process Development Engineer/Scientist (cGMP – Pharmaceutical)

Andover, MA area


DPS is looking for a proven Process Development resource to support a biopharmaceutical client in the Andover, MA area. The ideal candidate be responsible for designing, executing and supporting biologics downstream purification process including technology transfer activities both from the client(s) and internally to GMP manufacturing facility. 


Responsibilities:


  • Development of scale-able and robust downstream processes including process characterization, and/or technology transfer leading to clinical and commercial GMP manufacturing for multiple client projects.
  • Design experiments related to development, optimization, scale-up of all steps in a monoclonal antibody and bispecific antibody purification process and viral clearance study.
  • Identify, evaluate, and implement new and existing technologies to improve process efficiency, control, and understanding.
  • Apply DOE and other advanced statistical techniques to design experiments related to process characterization.
  • Author high-quality documents, including technical reports, SOPs, and experimental protocols.
  • Contribute to scale up activities and draft tech transfer related documents (e.g. process description, process flow diagram, etc.).
  • Support MFG floor activities and provide technical support (e.g. process/operational gap identification and troubleshooting) to MFG group.
  • Present data at client project teams and written reports.


Education and Requirements:


  • Ph.D. in life sciences or engineering with 5-8 years of relevant experience or equivalent BS/MS experience.
  • Solid theoretical knowledge and hands-on experience in protein purification and analytical characterization.
  • Hands-on experience with purification unit operations including filtration, different mode chromatography, UF/DF, AKTA, UNICORN, and centrifugation.
  • Advanced ability with Microsoft Office (Word, Excel, and PowerPoint).
  • Statistical data analysis experience required. JMP knowledge preferred.
  • Demonstrates ability to work both independently and as a member of local/global teams.
  • Excellent customer service skills and ability to meet client project deadlines.

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Process Development Engineer (cGMP – Pharmaceutical – Gene Therapy)

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